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Optimizing Outcome Assessment in Multicenter TBI Trials : Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative

BODIEN YG; MCCREA M; DIKMEN S; TEMKIN N; BOASE K; MACHAMER J; TAYLOR SR; SHERER M; LEVIN H; KRAMER JH; CORRIGAN JD; MCALLISTER TW; WHYTE J; MANLEY GT; GIACINO JT
J HEAD TRAUMA REHABIL , 2018, vol. 33, n° 3, p. 147-157
Doc n°: 187420
Localisation : Centre de Réadaptation de Lay St Christophe

D.O.I. : http://dx.doi.org/DOI:10.1097/HTR.0000000000000367
Descripteurs : AF3 - TRAUMATISME CRANIEN

Traumatic brain injury (TBI) is a global public health problem that affects the
long-term cognitive, physical, and psychological health of patients, while also
having a major impact on family and caregivers. In stark contrast to the
effective trials that have been conducted in other neurological diseases, nearly
30 studies of interventions employed during acute hospital care for TBI have
failed to identify treatments that improve outcome. Many factors may confound the
ability to detect true and meaningful treatment effects. One promising area for
improving the precision of intervention studies is to optimize the validity of
the outcome assessment battery by using well-designed tools and data collection
strategies to reduce variability in the outcome data. The Transforming Research
and Clinical Knowledge in TBI (TRACK-TBI) study, conducted at 18 sites across the
United States, implemented a multidimensional outcome assessment battery with 22
measures aimed at characterizing TBI outcome up to 1 year postinjury. In
parallel, through the TBI Endpoints Development (TED) Initiative, federal
agencies and investigators have partnered to identify the most valid, reliable,
and sensitive outcome assessments for TBI. Here, we present lessons learned from
the TRACK-TBI and TED initiatives aimed at optimizing the validity of outcome
assessment in TBI.

Langue : ANGLAIS

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